Expired Study
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Scottsdale, Arizona 85258


Purpose:

To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.


Criteria:

Inclusion Criteria: - Male and female children between 6 months and 4 years of age - Weight does not exceed 40 kg - Clinical diagnosis is acute otitis media - Have evidence of middle ear fluid - At risk for persistent or recurrent otitis media - Generally in good health Exclusion Criteria: - Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications - Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear - Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study - Concomitant infection, that requires additional antimicrobial therapy - Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response


Study is Available At:


Original ID:

M01-352


NCT ID:

NCT00645203


Secondary ID:


Study Acronym:


Brief Title:

Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media


Official Title:

An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

6 Months


Maximum Age:

4 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

447


Enrollment Type:

Actual


Study Dates

Start Date:July 2002
Primary Completion Date:April 2003
Primary Completion Type:Actual
Verification Date:March 2008
Last Changed Date:March 20, 2008
First Received Date:March 20, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Laboratory evaluations
Time Frame:30 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Adverse events assessment
Time Frame:45 days with follow-up to a satisfactory conclusion
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Physical exam; Vital signs; Use of concomitant medications
Time Frame:59 days
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Change in the otoscopic findings
Time Frame:30 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clinical response
Time Frame:30 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Bacteriological Response
Time Frame:30 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:cefdinir
Description:cefdinir oral suspension, 25 mg/kg once daily for 10 days
Arm Name:1
Other Name:ABT-198, Omnicef, cefdinir

Study Arms

Study Arm Type:Other
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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